Articles by n8n Publisher
FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: Key Lessons for Device Safety Programs
By n8n Publisher |
FDA updates alert on Nuwellis blood circuit issues as part of enhanced recall communication pilot,…
User Interface Software Errors Drive Medical Device Recalls: Critical Lessons for Manufacturers
By n8n Publisher |
Analysis of 2012-2015 FDA recall data reveals UI software errors as major recall driver. Learn…
Why Medical Device Recalls Can Signal a Healthy Quality System: FDA’s Perspective on Proactive Risk Management
By n8n Publisher |
Former FDA director's perspective reveals why proactive medical device recalls demonstrate robust quality systems and…
5 Critical Strategies to Reduce Medical Device Recall Risk in 2024
By n8n Publisher |
Medical device recalls jumped 10.8% in 2024. Learn five evidence-based strategies to minimize recall risk…
Understanding Medical Device Compliance: Key Regulatory Updates and Industry Best Practices
By n8n Publisher |
Explore the current medical device regulatory landscape and discover essential compliance strategies that manufacturers need…
Fast Company Spotlights Critical Gaps in Medical Device Recall Process: What Manufacturers Need to Know
By n8n Publisher |
Fast Company highlights critical gaps in medical device recall processes, emphasizing the need for manufacturers…
FDA Expands Early Alert Pilot Program: What Medical Device Manufacturers Need to Know
By n8n Publisher |
FDA expands Early Alert pilot program beyond initial five device categories, creating new compliance requirements…
High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons
By n8n Publisher |
Major 2024 medical device recalls including BioZorb, Cartiva, and Impella have triggered extensive litigation, revealing…
FDA Issues Class I Recall for Q’Apel Medical Aspiration System: Critical Compliance Lessons for Device Manufacturers
By n8n Publisher |
FDA upgrades Q'Apel Medical's aspiration system recall to Class I status, affecting 1,617 units. Learn…
Medtronic Pipeline Vantage 027 Urgent Recall: Critical Compliance Lessons for Medical Device Manufacturers
By n8n Publisher |
Medtronic's urgent Pipeline Vantage 027 recall offers critical compliance lessons for medical device manufacturers on…
